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Fluxergy Submits FDA EUA Request for One-Hour COVID-19 POC Test

By HospiMedica International staff writersPosted on 06 Apr 2020

Image: The Fluxergy Analyzer (Photo courtesy of Fluxergy LLC)

Fluxergy LLC (Irvine, CA, USA), a research and medical diagnostic test company, has submitted an Emergency Use Authorization (EUA) request to the U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health, seeking an authorization that would permit medical professionals to begin using the company’s high-speed Research Use Only (RUO) test system as a COVID-19 diagnostic at the point-of-care (POC).

Fluxergy provides a portable, highly sophisticated and easy to use sample-to-answer POC platform that enables clinicians to cost-effectively conduct a wide range of multiplex and multimodal in vitro diagnostic tests (different types of tests all at once, up to 30 targets). The company’s solution is a portable testing platform based on three core elements: the single-use consumable Fluxergy Card, the Fluxergy Analyzer, and its user interface Fluxergy Works. The Fluxergy Analyzer and the single-use consumable Fluxergy Cards (lab-on-chip) use proprietary printed circuit board (PCB) manufacturing and microfluidics technologies. Leveraging Fluxergy Works Software, as many as 256 Fluxergy Analyzers can be managed with one local server and linked to the Cloud to provide powerful access to help manage patient data.

The Fluxergy Analyzer system has been shown to accurately identify the SARS-CoV-2 virus in under one hour in bench lab tests performed by the company and in follow-up validation tests with patient samples completed this week by researchers at University of California San Diego. One of the advantages of the Fluxergy system is that it is lightweight and portable – the Fluxergy Analyzer is about the size of a small desktop personal computer – which makes it applicable in a variety of clinical settings. Importantly, the Fluxergy system also does not require the SARS-Cov-2 RNA to be purified before the test can be performed. Samples are placed directly on a disposable sample-to-answer Fluxergy test card, which uses printed circuit board technology and microfluidics to automate various sample processing steps.

Advanced rapid point-of-care PCR tests for COVID-19 like the Fluxergy Analyzer system may have the potential to save significant time compared to standard lab tests that must be shipped to centralized laboratories for processing. Fluxergy’s on-site sample-to-answer test for COVID-19 requires a very small sample, typically a nasal swab. This swab is mixed with a reagent solution, loaded onto the Fluxergy card and inserted into the Fluxergy Analyzer in a convenient two-step procedure.

"The worldwide shortage and inaccessibility of COVID-19 tests have been major impediments to containing the pandemic in the US and globally,” said Dr. Ali Tinazli, Chief Commercial Officer at Fluxergy. “We are gratified to be progressing toward the next important milestone in the development of our point-of-care diagnostic technology.”